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Optimizing the Approach to IRT Customization

The clinical randomization and supply chain management systems we now dub “IRT” were initially built as fully customized IT projects, individualized and implemented separately for each study. While the processes have improved since then and some IRT providers are now using systems designed for more configurability, the mindset of customizing IRT systems for each study persists.

Sponsors have developed a level of comfort with this approach and also benefit in their ability to define the functionality of the system at a very detailed level. But, what are the costs and challenges compared to adopting a more agile approach using a highly configurable IRT system?

The Problem

Let’s assume we are working with a typically modern IRT system, where much of the study build will use established modules and/or configuration capabilities within the system. Some level of delivery will be considered customization though, where developers build capabilities or alter the standard modules to meet the protocol and study team requirements.

The key and most obvious costs revolve around the broad team required to provide the customization. Typically, the effort requires a project manager, developers, testers and some level of support personnel (business analysts, technical writers, etc.). Beyond the obvious financial cost that comes from more resources, there is additionally a need for effective communication among several people and the corresponding risk of error when communication is not effective at any level. For instance, developers are highly skilled technical resources, but often do not have a deep understanding of the clinical business. When misunderstandings occur, there can be schedule delays and/or additional and unexpected costs – or even patient risk - during study execution.

A related risk and corresponding cost are the increased difficulty in demonstrating the customized functionality to the study team and decision makers. The demonstration requires the customization to have reached a level of stability, which usually means waiting until well into the project timeline. Uncovered issues late in the project multiply the cost and risk of the system throughout its lifetime or mean delays in study start (which is usually not an option).

There are also less evident costs of customized IRT deliveries:

During study execution, issues are more likely to occur that can only be handled by the study staff who have received comprehensive study-specific training. This can lead to delays since it is difficult, expensive or impossible to ensure these resources are immediately available 24x7.

The user interface might be less intuitive. Site users who have used the system for other studies may be confused by the change in interface, leading to delays in processing clinical events and/or lack of compliance.

Study amendments will likely be more expensive as well as more time-consuming and difficult to implement.

The Solution

At Bioclinica, we believe customization should be avoided where possible, but, when required, it should be handled in as standard and controlled a manner as possible. There are three approaches we take to limit the risk and impact of customization.

Eliminate the need for customization in the first place

The Trident IRT system is designed to maximize configurability to support any protocol design. For most studies, there are no modules to glue together, nor any need for developer involvement at all. There is one, highly configurable system. Our build team, therefore, is the same IRT business expert that is also directly communicating with the study team, not a remote team of software developers.

We are also committed to continuous innovation. We have an ongoing goal of 100% protocol coverage, toward which we are progressing in every core system release by expanding the coverage of configurability, based on industry trends and direct customer experience.

Support building-block reusable customization

Another design tenet of the Trident system is that it must be possible to encapsulate customizations into small pieces with clear functional behavior. The system must further support the ability to configure the inputs and orchestrate the workflow of several functions as well as the core system and site user interface together to reach the desired functionality. All of this must be editable via a rich graphical administrative interface and thus accessible and understandable to non-programmers.

Limit the impact of customization to a single study

Finally, the Trident system is designed to have customization support built-in and applicable (by configuration) to individual studies. Thus, customization applied for one study will never impact another study on the system. This architectural foundation is crucial, allowing studies to be customized without a need to regression test or worry about other studies. Despite the constraints on how customization is applied, the system nevertheless provides the full power of a programming language and enterprise server environment to the customization team.

Beyond these product-based approaches, Bioclinica empowers its project management teams to collaborate with our clients’ study teams to help them design IRT implementations that not only meet the protocol and study team needs but also align with best practices for low-risk study build and execution, including the elimination of or standardization of custom implementations by the development teams.